drugset / Trial / NCT01110044
Study of a Birth Dose of GlaxoSmithKline Biologicals' 251154 Vaccine
RandomizedParallel-groupOpen-labelPrevention
Summary
The purpose of the study is to evaluate the safety and immunogenicity of a birth dose of GSK Biologicals' reduced-antigen-content tri-component pertussis (251154) vaccine followed by routine paediatric vaccination.
Timeline
- Start
- 2010-04
- Primary completion
- 2012-08
- Completion
- 2012-08
Outcome
Outcome not reported
Stopped: “Study was cancelled before enrolment for reasons not related to vaccine safety or efficacy.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 251154 | Vaccine | — | Intramuscular |
| Background | Infanrix hexa | Vaccine | — | Intramuscular |
| Background | Rotarix | Vaccine | — | Oral |
| Background | Synflorix | Vaccine | — | Intramuscular |